Indications and Usage

Active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine; active immunization of infants and toddlers against invasive disease caused by S. pneumoniae because of capsular serotypes included in the vaccine.

Contraindications

Hypersensitivity to any component of the vaccine, including diphtheria toxoid.

Dosage and Administration

IM 3 doses of 0.5 mL each at approximately 2-mo intervals, followed by a fourth dose of 0.5 mL at 12 to 15 mo of age. Usually the first dose is at 2 mo of age; however, it can be given as young as 6 wk of age. The recommended dosing interval is 4 to 8 wk. Administer the fourth dose at least 2 mo after the third dose.

Previously Unvaccinated Older Infants and Children Beyond Age of Routine Infant ScheduleChildren at least 24 mo through 9 y of age ( Prevnar )

IM 1 dose of 0.5 mL.

Children at least 24 mo through 5 y of age ( Prevnar 13 )

IM 1 dose of 0.5 mL.

Children 12 to 23 mo of age

IM 2 doses of 0.5 mL at least 2 mo apart.

Children 7 to 11 mo of age

IM 3 doses of 0.5 mL; administer 2 doses at least 4 wk apart and the third dose after the 1-y birthday. Administer the third dose at least 2 mo after the second dose.

Prevnar 13 Schedule for Children Previously Vaccinated With PrevnarChildren who previously received 1 or more doses

General Advice

Preferred sites of IM injection are the anterolateral aspect of the thigh in infants or deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.

For IM injection only. Not for IV, subcutaneous, or intradermal administration.

Miscellaneous

Precautions

Pregnancy

Lactation

Children

Safety and efficacy not established in children younger than 6 wk of age or after the tenth birthday ( Prevnar ) or after the sixth birthday ( Prevnar 13 ).

Elderly

Not recommended for use in adult population.

Special Risk Patients

Pneumococcal 7-valent conjugate vaccine does not replace the 23-valent pneumococcal polysaccharide vaccination in children 24 mo of age and older with sickle cell disease, asplenia, HIV infection, or chronic illness, or those who are immunocompromised.

Bleeding disorders

Do not give to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate IM injection unless the benefits clearly outweigh the risk of administration.

Efficacy

Will not protect against S. pneumoniae disease other than that caused by the 7 serotypes included in the vaccine.

Febrile illness

Postpone administration in patients suffering from acute severe febrile illness. Minor illnesses, such as mild respiratory infection with or without low-grade fever, are generally not contraindications to vaccination.

Fever/Seizures

Fever and, rarely, febrile seizures have been reported in children. For children at higher risk of seizures than the general population, appropriate antipyretics may be given around the time of vaccination to reduce the possibility of postvaccination fever.

Immunocompromised patients

May have reduced response to immunization.

Premature infants

Apnea following IM vaccination has been observed in some infants born prematurely.

Overdosage

Symptoms

Most individuals experiencing overdosage were asymptomatic.

Patient Information

Advise parent or guardian that vaccine provides protection against the 7 most common ( Prevnar ) or 13 most common ( Prevnar 13 ) serious pneumococcal infections in infants and toddlers but does not provide protection from other causes of bacterial infection.

Review immunization schedule and advise parent or guardian that entire series must be completed to provide maximum benefit.

Provide parent or guardian with vaccine information and immunization history record.

Advise parent or guardian to use OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.

Advise parent or guardian to notify health care provider if bothersome adverse effects last more than 24 h.

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.